Sanofi-Aventis (New Jersey) Release: New Study Shows Burden Of Venous Thromboembolism (VTE) For Americans

ATLANTA, Dec. 14 /PRNewswire-FirstCall/ -- New findings presented at the 47th annual meeting of the American Society of Hematology (ASH) here show that each year, hundreds of thousands of Americans die from complications of blood clots in veins (deep-vein thrombosis [DVT]), a potentially preventable condition.

A study was conducted by researchers from several institutions including Mayo Clinic and University of Massachusetts Medical School, to investigate the prevalence of DVT and its often fatal complication, pulmonary embolism (PE), which together are commonly referred to as venous thromboembolism (VTE). Findings revealed that more than 600,000 people in the US suffer from non-fatal VTE events each year (DVT, n=376,365; PE, n=237,058). There are almost 300,000 fatal VTE events each year (296,370), and only seven percent of those who died were diagnosed and treated. Almost 60 percent of the fatal events followed undetected VTE (174,115). Additionally, approximately one-third of VTE events were not related to extended in-hospital immobilization, while two-thirds resulted from extended in-hospital immobilization.

“This study demonstrates that nearly one million people in the U.S. still develop VTE each year and almost one-third are fatal,” said John Heit, M.D., one of the study’s investigators and professor of Medicine at Mayo Clinic College of Medicine. “It also shows that the most fatal PE events either occur suddenly or follow asymptomatic and unrecognized DVT. DVT must be prevented in order to avoid these deaths, and over two-thirds of US VTE were related to hospitalization where safe and effective DVT prophylaxis is available.”

Entitled “Estimated Annual Number of Incident and Recurrent Non-Fatal and Fatal Venous Thromboembolism (VTE) Events in the U.S.,” the study concluded that VTE is a serious health problem in the U.S. and suggested that safe and effective prophylaxis could significantly reduce the national incidence of DVT, PE and related deaths.

“Complications from DVT kill more people each year in the U.S. than breast cancer and AIDS combined -- and it’s a condition that is preventable and treatable in many cases,” said Mark Jablonski, President of the national non-profit patient advocacy group National Alliance for Thrombosis and Thrombophilia (NATT). “This study sheds light on the fact that many people affected by DVT and PE are not getting the timely diagnosis and treatment they need to survive. The data are extremely useful to start discussing health care delivery issues surrounding DVT and PE and identifying the solutions that could potentially save tens of thousands of lives.”

This study is the US arm of a larger global VITAE study, VTE Impact Assessment Group in Europe, the first major attempt to establish the actual burden of VTE across the European Union. VITAE investigators, a panel of European and North American Thrombosis experts, estimated the total annual

burden of VTE across 25 EU countries by combining data from clinical, epidemiological and autopsy studies.

U.S. Study Design

Researchers developed an incidence-based model that included both hospital- and community-acquired VTE events, as well as death from recognized and unrecognized VTE, as follows:

* The annual number of community-acquired events were estimated using the average age-, sex-, and event-specific incidence rates in Olmsted County, MN (1966-1990) and Y2000 US census data. * The annual number of hospital-acquired events were estimated using patient age and Y2002 International Classification of Disease (ICD-9) discharge diagnosis codes for major surgery types or acute medical illnesses within the Healthcare Cost and Utilization Project database. * The annual number of VTE events was estimated based on the published probability of VTE with and without prophylaxis, and US prophylaxis rates, by risk group. * Fatal and recurrent events were estimated based on published data. Sensitivity analyses were used to test the effects of VTE and prophylaxis rate uncertainty on the estimates. About VTE

Venous thromboembolism (VTE) refers to two serious conditions: Deep-Vein Thrombosis (DVT) and Pulmonary Embolism (PE). DVT is a condition resulting from the formation of a blood clot inside a deep vein, commonly located in the calf, thigh or pelvis. DVT occurs when the blood clot either partially or completely blocks the flow of blood in the deep vein. As opposed to clots causing stroke or heart attack, these clots and veins are quite large (about as big as around one’s thumb) and may extend from below the knee to above the groin. PE is a potentially life-threatening complication and occurs when a fragment of a blood clot breaks loose and travels to the lungs.

Certain individuals may be at increased risk for developing DVT; however, it can occur in almost anyone. Some of the common at-risk situations include trauma or major surgery, such as hip or knee replacements, as well as acute medical situations (stroke, heart failure, respiratory failure or infections), especially if the patient’s mobility is reduced or the patient has other risk factors such as advanced age, obesity, varicose veins, history of DVT or cancer, or among women, oral contraceptives, pregnancy or post partum, or hormone therapy. Some individuals have inherited or acquired conditions that predispose to thrombosis, termed thrombophilia. Measures for preventing DVT include avoidance of immobilities or early mobilization after surgery or childbirth, sequential compression devices and stockings to augment blood flow and anticoagulants (e.g. “blood-thinning drugs”) to prevent blood clotting.

About VITAE

This study used epidemiological modeling, an approach that has become increasingly accepted when derivation of the frequency of a disease by performing clinical or epidemiological studies is impractical. VITAE study is the first major attempt to establish the total burden of VTE across the whole EU and US including the morbidity, mortality complications and the costs associated with this medical condition. The VITAE study was sponsored by sanofi-aventis.

This press release was developed in cooperation between NATT and sanofi-aventis.

About NATT

The National Alliance for Thrombosis and Thrombophilia (NATT) is a nationwide, community-based, volunteer, patient-driven health organization formed in August 2003. Committed to preventing and treating the array of major health problems caused by blood clots, NATT is quickly being recognized as the premier community-based non-profit organization dedicated to prevention and treatment issues in thrombosis and thrombophilia in the United States. NATT’s goal is to ensure that people suffering from thrombosis and thrombophilia get early diagnosis, optimal treatment and quality support by fostering research,

education, support, and advocacy on behalf of those at risk of, or affected by, blood clots. For more information, visit http://www.nattinfo.org .

About sanofi-aventis

The sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris and in New York .

sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

Reference

Heit JA, Cohen AT. Anderson FA et al on behalf of the VTE Impact Assessment Group. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the U.S. Poster 68 presented at: American Society of Hematology, 47th Annual Meeting, Atlanta, GA, December 10-13, 2005.

Contacts: Denise Scalzo May Baccari Office: 212-845-4241 Office: 212-845-4279 Cell: 917-667-8791 Cell: 253-230-3789 denise.scalzo@eurorscg.commay.baccari@eurorscg.com

NATT

CONTACT: Denise Scalzo, Office: +1-212-845-4241, Cell: +1-917-667-8791,denise.scalzo@eurorscg.com; or May Baccari, Office: +1-212-845-4279, Cell:+1-253-230-3789, may.baccari@eurorscg.com